Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations

Beenish Hassan

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Post-operative Sensitivity; Dental Caries; Tooth Sensitivity After Composite Restorations; Dentin Hypersensitivity; Post-operative Sensitivity After Class I Composite Restorations

Treatments: Drug: Drug/Agent: No desensitizer (Control); Drug: Drug/Agent: Gluma Desensitizer

Study type: Interventional

Funder types: Other

Identifiers

NCT07188142

DB/272/25

Details and patient eligibility

About

• The aim of this study is to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -Patients visiting OPD will be selected after fulfilment of inclusion criteria. Patients aged 18-45 meeting inclusion criteria and presenting with active primary class I carious lesions on vital molar teeth with ICDAS score 3 will be randomly assigned into two groups: -Group A: Patients will be provided with Gluma desensitizer, Universal Bonding agent and Composite restoration and -Group B: Patients will receive Universal bonding agent and Composite restoration. -The progress of treatment will be followed up immediately (baseline) and at regular follow up visits at 1 week, 1 month and 3 months.
• Post-operative sensitivity will be assessed using an air stimulus and rated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10.

Full description

-This randomized clinical trial is done to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -The study sample size includes a total of 60 participants aged 18 to 45, each having two Class I carious lesions requiring composite restorations. -Patients will be randomly divided into two groups using a lottery method: -Group A receiving Gluma desensitizer, universal bonding agent, and composite restoration, and -Group B receiving universal bonding agent and composite restoration without desensitizer. -Patients will be selected from the outpatient dental clinic after fulfilling inclusion criteria, which include age between 18 and 45 years, good oral hygiene, active primary Class I carious lesions on vital molar teeth with an ICDAS score of 3, complaints of sensitivity to air and osmotic stimulus, positive response to cold test, and no signs of pulp inflammation or spontaneous pain before treatment. -Exclusion criteria include excessive tooth wear due to clenching or abnormal habits, traumatic occlusion, periodontal or gingival disease, and current use of analgesics and/or anti-inflammatory medication. -Post-operative sensitivity will be measured clinically using an air stimulus and evaluated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10. ranging from 0 (no sensitivity) to 10 (unbearable sensitivity) at baseline (immediately after treatment) and at 1 week, 1 month, and 3 months postoperatively. -Statistical analysis will be performed using non-parametric tests including the Friedman test for within-group comparisons and Wilcoxon signed-rank test for between-group differences, with significance set at p < 0.05. -This study will further add to the literature by providing clinical evidence regarding the efficacy of Gluma desensitizer in reducing post-operative sensitivity and improving patient comfort following restorative dental procedures.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-45 years.
• Good oral hygiene.
• Active primary class I carious lesions on vital molar teeth with ICDAS score 3
• Patients complaining of sensitivity to air and osmotic stimulus.
• Teeth having a positive cold test.
• No signs of pulp inflammation or spontaneous pain before treatment.

Exclusion criteria

• Excessive tooth wear due to clenching or abnormal habits.
• Traumatic occlusion.
• Periodontal or gingival disease.
• Patients using analgesics and/or anti-inflammatory medicine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Active Comparator: Group A (Gluma Desensitizer Group)

Active Comparator group

Description:

Patients receiving Gluma desensitizer followed by universal bonding agent and composite restoration on Class I carious lesions.

Treatment:

Drug: Drug/Agent: Gluma Desensitizer

Active Comparator: Group B (Control Group)

Active Comparator group

Description:

Patients receiving universal bonding agent and composite restoration without Gluma desensitizer on Class I carious lesions.

Treatment:

Drug: Drug/Agent: No desensitizer (Control)